Prospective Sirolimus Coated Angioplasty for Arterial Disease in Patients Presenting Chronic Limb-Threatening Ischemia Study (PROSCAD-CLTI STUDY).

Abstract

Background: Angioplasty in chronic limb-threatening ischemia (CLTI) with paclitaxel-coated device has raised doubts on its long-term safety. Consequently, sirolimus-coated balloons (SCBs) have gained more interest given a better safety profile, maintaining good outcomes. This study aims to evaluate the safety and efficacy of SCB (SELUTION SLR; M.A. Med Alliance SA, Nyon, Switzerland) for femoropopliteal arterial disease in patients presenting with CLTI.

Methods: This prospective, single-center study included patients with CLTI with femoropopliteal arterial disease treated between October 2022 and July 2024. Exclusion criteria included planned primary amputation and long-segment occlusions (>25 cm) of the femoropopliteal axis. Primary endpoints were technical success and primary patency (PP). Primary patency was defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. Secondary endpoints included mortality, clinically driven target lesion revascularization, freedom from reintervention, and from major amputation.

Results: A total of 24 patients were treated during the study period with a mean lesion length of 152 ± 54.7 mm. All procedures were conducted successfully. One early death occurred after 3 days of the index procedure because of worsening of pre-existing cardiac failure. At 30 months, PP, mortality, and freedom from major amputation were 95.5%, 91.7%, and 95.7%, respectively.

Conclusions: These findings suggest that using an SCB is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in CLTI. These results will need to be confirmed by long-term follow-up and randomized controlled trials.Clinical ImpactConcerns about paclitaxel-coated devices have driven the search for safer alternatives. Sirolimus-coated balloons (SCBs) have demonstrated promising results in terms of primary patency and freedom from clinically driven target lesion revascularization. The SELUTION SLR SCB, with its unique drug delivery technology, emerges as a strong candidate in this context. This observational study aims to evaluate its performance in treating femoropopliteal arterial disease in patients with chronic limb-threatening ischemia. Overall, the SELUTION SLR shows encouraging and consistent outcomes in this challenging patient population.